Title of Service
Clinical Trials: Medicines & Driving task
Who are our clients?
Indicative interested parties are the following:
- Drug companies
- Research institutes and centres carrying out research that have no or limited ‘know-how’ and/ or technical infrastructure
- Organizations and public bodies/ centres
The overarching goal is to reduce Driving Under the Influence of Medicines (DUIM) accidents through the following activities:
- Inform healthcare professionals about the effects of medicines on driving performance;
- Effect on driving performance of patients under medication;
- Efficient and effective dissemination of results from studies conducted in collaboration with pharmaceutical companies;
- Increasing the reliability and enhancing the social profile of pharmaceutical companies.
CERTH/ HIT has the capacity and experience to talk up the complete and entire process of investigating the effect of medicines on driving ability and behaviour or partially support specific aspects of the research/ study, such as the following:
- Study design
- Research protocol submission/Approval by National Medicine Organization (EOF)
- Conduction, management and monitoring of simulated driving experience experiments
- Data management
- Statistical analyses
- Contact with regulatory authorities
- Quality assurance
- Public dissemination
Figure 1. Holistic service provision
Testing in simulated environment (for a two-month study) requires half the duration and cost from conducting the experiments on the road (€175 000) (MEDSCAPE, 2013). Indicative cost estimation for the whole study is € 79,950 and it can be translated into a saving of 46%-123%. The team is experienced in applying the Tiered approach (NHTSA & FDA, 2011) and can efficiently support international studies apart from national research efforts. Definite cost estimation is possible only after consultation with the research team.
6th km Charilaou-Thermis